DIAZEPAM Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Meridian Medical Technologies, Inc.

Λέξεις κλειδιά

11704-600

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1. Description

Diazepam injection is a sterile solution packaged within a device that delivers its entire 2 mL contents automatically upon activation. Each mL contains 5 mg diazepam compounded with 40% propylene glycol, ...

2. Clinical Pharmacology

In animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral ...

3. Indications and Usage

Diazepam is indicated for the management of anxiety disorders for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require ...

4. Contraindications

Intravenous administration of diazepam with the autoinjector is contraindicated Diazepam injection is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; ...

5. Warnings

Risks from Concomitant Use With Opioids Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, ...

6. Precautions

Administration Considerations Long Term Control of Seizures Although seizures may be brought under control promptly with a single 10 mg intramuscular dose, a significant proportion of patients may experience ...

6.4. Drug Interactions

Effect of Concomitant Use of Benzodiazepines and Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in ...

6.7. Pregnancy

An increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate and chlordiazepoxide) during the first trimester of pregnancy has been suggested in several ...

6.10. Pediatric Use

Efficacy and safety of parenteral diazepam has not been established in the neonate (30 days or less of age). Prolonged central nervous system depression has been observed in neonates, apparently due to ...

7. Adverse Reactions

Side effects most commonly reported were drowsiness, fatigue and ataxia; venous thrombosis and phlebitis at the site of injection. Other adverse reactions less frequently reported include: CNS: ...

8. Drug Abuse and Dependence

Diazepam injection is classified by the Drug Enforcement Administration as a schedule IV controlled substance. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, ...

9. Overdosage

Manifestations of diazepam overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage, although, ...

10. Dosage and Administration

Administration of the Diazepam Autoinjector Pull off gray safety cap Place Black end on mid outer thigh Push hard until injector functions Withdraw after 10 seconds Dosage Caution: Because the ...

11. How Supplied

Diazepam injection, 5 mg per mL, is available in 2 mL Disposable Autoinjectors. Office of the Surgeon General, U.S. Army Medical Research and Development Command (MCMR-RCQ-HR), Fort Detrick, Frederick, ...

12. Animal Pharmacology and/or Animal Toxicology

Oral LD50 of diazepam is 720 mg/kg in mice and 1240 mg/kg in rats. Intraperitoneal administration of 400 mg/kg to a monkey resulted in death on the sixth day. Reproduction Studies A series of ...

13. Storage and Handling

Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Do not refrigerate.

BOXED WARNING SECTION

0.102 WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see ...